ACL TOP — Class II medical device recall Z-2060-2014
Terminated recall by Instrumentation Laboratory Co., reported 2014-07-23, distributed nationwide. Potential for sample misidentification.
| Recall number | Z-2060-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory Co., Bedford, MA, United States |
| Recall initiated | 2014-06-03 |
| Classified | 2014-07-16 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2017-09-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BO, BR, CA, CH, CL, CN, CR, CZ, DE, DK, DO, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JP, KR, KW, LT, LU, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, RO, RS, RU, SA, SE, SI, SK, SV, TH, TN, TR, TW, UY, VE, VN, ZA |
| Quantity | 1,074 |
Product
ACL TOP (Base), automated coagulation laboratory instrument.
Reason for recall
Potential for sample misidentification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2060-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.